RecruitingPhase 2Phase 3NCT03804931

Fecal Microbiota Transplantation for Ulcerative Colitis

Efficacy and Safety of Fecal Microbiota Transplantation for Ulcerative Colitis


Sponsor

Guangzhou First People's Hospital

Enrollment

120 participants

Start Date

Jan 20, 2019

Study Type

INTERVENTIONAL

Conditions

Summary

Fecal microbiota transplantation (FMT) is a strategy that infuses a fecal suspension containing a healthy donor's microbiota into a patient's gut to restore his/her intestinal microbiome. Fecal microbiota transplantation has been used for several disease,but the efficacy of ulcerative colitis(UC) by fecal microbiota transplantation needs to be further explored.The investigators propose to determine the efficiency and safety of FMT in patients with ulcerative colitis(UC).


Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This trial is testing whether a "fecal microbiota transplant" (FMT) — transferring healthy gut bacteria from a donor into a patient's colon — can help treat moderate to severe ulcerative colitis, a chronic bowel disease that causes inflammation and sores in the colon. **You may be eligible if...** - You have been diagnosed with active, moderate to severe ulcerative colitis - Your condition has been assessed using a standard scoring system (Mayo score above 6) - You have previously used a medication called 5-ASA (a common ulcerative colitis drug) - You are able to undergo a scope procedure (endoscopy) to examine your colon **You may NOT be eligible if...** - You have taken antibiotics in the past 7 days - You have signs of a life-threatening complication called toxic megacolon (extreme colon swelling) - You have colon cancer or pre-cancerous tissue - You have another serious illness affecting the heart, lungs, gut, or kidneys Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

PROCEDUREFecal microbiota transplantation

200 mL of prepared fecal microbiota suspension from healthy donors' fresh feces was injected into the intestine

PROCEDUREInfusion of Saline

Infusion of Saline

DRUG5-Aminosalicylic acid(5-ASA) and/or Prednisone

Mesalazine and/or Prednisone


Locations(1)

Guangzhou First People's Hospital

Guangzhou, Guangdong, China

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NCT03804931


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